September 2016 SPDS Book

Method Performance Requirements for Determination in Plant & Meat-Derived Proteins

Parameter

Criteria

Analytical Range (%)

0 1 – 100 . 

LOQ  (%)

0.050

LOD  (%)

0.025

90‐110 (0.1 – 1% range) 97‐103 (>1 – 100% range) ≤ 10 (0.1 – 1% range) ≤ 6 (>1 – 100% range) ≤ 12 (0.1 – 1% range) ≤ 8 (>1 – 100% range)

Recovery (%)

% RSD r

% RSD R

Single-Lab Method Performance Requirements for Identification in Plant & Meat-Derived Proteins

Parameter  Requirements

Target Test  Conc

Minimum Acceptable Results 90% POI (95%  confidence interval) of the pooled data for  all target compounds  and matrices.

Study

Parameter 

POI @ low conc

≥ 33 reps representing  all listed target analytes

0.1 %

≥ 5 reps per matrix type  spiked at 10x the  designated low level  target test conc

Matrix

POI @ high conc

10%

100% correct analyses  are expected

POI @  zero conc

≥ 5 reps per matrix type 

0 %

Evaluate samples  containing  non‐protein ingredients  and listed adulterants

False positive  rate

10 %

≤ 5%

Selectivity